Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
Reported: December 11, 2024 Initiated: November 14, 2024 #D-0100-2025
Product Description
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Details
- Recalling Firm
- Amerisource Health Services LLC
- Units Affected
- 23,490 bottles
- Distribution
- PA, OH, PR
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories. Recalled by Amerisource Health Services LLC. Units affected: 23,490 bottles.
Why was this product recalled? ▼
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 11, 2024. Severity: Moderate. Recall number: D-0100-2025.
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